adroitmedical.comSOFT AIR, MODEL SA 4000 AND MISTRAL AIR, MODEL MA0100
ADROIT MEDICAL SYSTEMS, INC.
ADROIT MEDICAL SYSTEMS, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1055823 | 1000111140 | ADROIT MEDICAL SYSTEMS, INC. | 1 | N | 2026-01-01 | 1146 CARDING MACHINE RD. LOUDON TN US 37774 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 10615089100304 | Soft-Temp - Pad Heat Neck 4 x 19 in. (Filled Dimensions) Non-Woven Fabric Both Sides Latex/PVC Free Disposable. | 8654588600 | kelley@adroitmedical.com |
| 10615089100809 | Soft-Temp - Pad for Motorized Cold Therapy Foot Non-Sterile 6x8in. | 8654588600 | kelley@adroitmedical.com |
| 10615089101004 | Soft-Temp - Pad for Motorized Cold Therapy Unit Hand Non-Sterile 5x10in. | 8654588600 | kelley@adroitmedical.com |
| 10615089101400 | Soft-Temp - Pad for Motorized Cold Therapy Unit Thigh Non-Sterile 8x14in. | 8654588600 | kelley@adroitmedical.com |
| 10615089101707 | Soft-Temp - Pad Heat Small 12 x 17 in. (Filled Dimensions) Non-Woven Fabric Both Sides Latex/PVC Free Disposable | 8654588600 | kelley@adroitmedical.com |
| 10615089101905 | Soft-Temp - Ankle Pad, Insulated, Velcro Fasteners. | 8654588600 | kelley@adroitmedical.com |
| 10615089102407 | Soft-Temp - Pad Heat Large 18 x 24 in (Filled Dimensions) Non-Woven Fabric Both Sides Latex/PVC Free Disposable | 8654588600 | kelley@adroitmedical.com |
| 10615089103008 | Soft-Temp - ST-030 | 8654588600 | kelley@adroitmedical.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 45398 | 1779287561 | K990175 | SHEATHES (NON-LATEX), STERILE | ITX | 1999-04-21 |
| 45398 | 1364361027 | K970197 | HTP-1500 LOCALIZED HEAT THERAPY PUMP | ILO | 1997-09-10 |
| 45398 | 1017236719 | K921928 | SOFT-COVER | FMW | 1992-11-06 |
| 45398 | 1395978799 | K921920 | SOFT-TEMP | DWJ | 1992-12-11 |
| 45398 | 1251063339 | K101705 | MISTRAL-AIR WARMING SYSTEM | DWJ | 2010-07-02 |
| 45398 | 1724411166 | K073712 | SOFT AIR, MODEL SA 4000 AND MISTRAL AIR, MODEL MA0100 | DWJ | 2008-06-06 |
| 45398 | 1046258181 | ||||
| 45398 | 1814042996 | ||||
| 45398 | 2055955236 | ||||
| 45398 | 1251063339 | ||||
| 45398 | 1779287561 |
Product Codes Associated With Registrations#
PMN#
SAFEPASS STERILIZATION POUCH
ADROIT MEDICAL SYSTEMS, INC.
HTP-1500 LOCALIZED HEAT THERAPY PUMP
ADROIT MEDICAL SYSTEMS, INC.
STERILE SOFT-TEMP
ADROIT MEDICAL SYSTEMS, INC.
SOFT-TEMP
ADROIT MEDICAL SYSTEMS, INC.
SOFT-COVER
ADROIT MEDICAL SYSTEMS, INC.
GUDID#
Soft-Temp - Pad Heat Neck 4 x 19 in. (Filled Dimensions) Non-Woven Fabric Both Sides Latex/PVC Free Disposable.
2016-09-23
Soft-Temp - Pad for Motorized Cold Therapy Foot Non-Sterile 6x8in.
2016-09-23
Soft-Temp - Pad for Motorized Cold Therapy Unit Hand Non-Sterile 5x10in.
2016-09-23
Soft-Temp - Pad for Motorized Cold Therapy Unit Thigh Non-Sterile 8x14in.
2016-09-23
Soft-Temp - Pad Heat Small 12 x 17 in. (Filled Dimensions) Non-Woven Fabric Both Sides Latex/PVC Free Disposable
2016-09-23
Soft-Temp - Ankle Pad, Insulated, Velcro Fasteners.
2016-09-23
Soft-Temp - Pad Heat Large 18 x 24 in (Filled Dimensions) Non-Woven Fabric Both Sides Latex/PVC Free Disposable
2016-09-23
Soft-Temp - ST-030
2016-09-23
Soft-Temp - Arm Pad 8.5 x 9.5 in. Elastic Mesh.
2016-09-23
Soft-Temp - Leg Pad, 12 x 14.5 in. , Elastic Mesh
2016-09-23
Soft-Temp - Patient Vest, Poncho Style, Elastic Straps
2016-09-23
Soft-Temp - Head Wrap
2016-09-23
Soft-Temp - Pad Heat Small 12x17 in (Filled Dimensions) All Polymer Latex/PVC Free Disposable
2016-09-23
Soft-Temp - Pad Heat Medium 14x20 in (Filled Dimensions) All Polymer Latex/PVC Free Disposable
2016-09-23
Soft-Temp - Blanket Pediatric 24x30 in. (Filled Dimensions) Hyper-Hypothermia All Polymer Latex/PVC Free Disposable
2016-09-23
Soft-Temp - Blanket Adult 24x60 in. (Filled Dimensions) Hyper-Hypothermia All Polymer Latex/PVC Free disposable.
2016-09-23
Soft-Temp - Pad for Motorized Cold Therapy Unit Shoulder Non-Sterile 12x12in w/straps.
2016-09-23
Soft-Temp - Pad Heat Small 12x17in (Filled Dimensions) Non-Woven Medium Weight Fabric Both Sides Latex/PVC Free Disposable.
2016-09-23
Soft-Temp - Pad Heat Medium 14x20in (Filled Dimensions) Non-Woven Medium Weight Fabric Both Sides Latex/PVC Free Disposable
2016-09-23
Soft-Temp - Pad Heat Large 18x24in (Filled Dimensions) Non-Woven Medium Weight Fabric Both Sides Latex/PVC Free Disposable.
2016-09-23
Soft-Temp - Blanket Pediatric 24x30in (Filled Dimensions) Hyper-Hypothermia Non-Woven Medium Weight Fabric Both Sides Latex/PVC Free disposable.
2016-09-23
ThermalX - Youth Cap
2019-10-04
ThermalX - Adult Cap
2018-12-01
ThermalX - Jacket Medium, All Silver
2019-10-04
ThermalX - Jacket Large, All Silver
2019-10-04
ThermalX - Small Pulse Oximetry Mitt
2019-10-04
ThermalX - Medium Pulse Oximetry Mitt
2019-10-04
Soft-Temp - Leg Wrap
2016-09-23
Soft-Temp - Hyper-Hypothermia Patient Vest.
2016-09-23
Soft-Temp - Blanket Adult 24x60 in. (Filled Dimensions); Hyper-Hypothermia Non-Woven Fabric Both Sides; Latex/PVC Free; Disposable.
2016-09-23
Soft-Temp - Chilly Kit w/Head Wrap, Patient Vest and Blanket Wrap for Legs
2016-09-23
Soft-Temp - Pad Heat Large 18x24in (Filled Dimensions) All Polymer Latex/PVC Free Disposable.
2016-09-23
Surface Warming & Cooling System - A3
2020-10-01
Soft-Temp - Neck Pad, insulated, Velcro Fastener
2016-09-23
Soft-Temp - Pad for Motorized Cold Therapy Knee Non-Sterile 12x12in.
2016-09-23
Soft-Temp - Pad for Motorized Cold Therapy Unit Back Non-Sterile 12x17in.
2016-09-23
Soft-Temp - ST-020
2016-09-23
Soft-Temp - Wrist Pad, Insulated, Velcro Fasteners
2016-09-23
Soft-Temp - Leg Pad, Insulated, Velcro Fasteners.
2016-09-23
Soft Air - Blanket, Upper Body, Reflective, White
2017-03-15